Citomid (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Lemery, S.A. de C.V. (Mexico)

ATC Code

L01CA02 (Vincristine)

Active Substance

Vincristine (Rec.INN registered by WHO)

Dosage Form

Citomid

Lyophilized powder for the preparation of solution for injection 1 mg: fl. 1 pc. in a set with solvent

Dosage Form, Packaging, and Composition

1 mg – vials (1) in a set with solvent – cardboard packs.

Clinical-Pharmacological Group

Antineoplastic drug

Pharmacotherapeutic Group

Antineoplastic agent – alkaloid

Pharmacological Action

Antineoplastic agent. The mechanism of action is associated with the blockade of tubulin and the arrest of cell division in the metaphase.

Pharmacokinetics

Penetrates the blood-brain barrier in insignificant amounts. Plasma protein binding is about 75%. It is biotransformed in the liver. It is excreted mainly as metabolites, with bile (about 67%) and by the kidneys (about 12%).

Indications

Acute leukemia, lymphogranulomatosis, non-Hodgkin’s lymphomas, multiple myeloma, rhabdomyosarcoma, Ewing’s sarcoma, sarcoma of bones and soft tissues, osteogenic sarcoma, neuroblastoma, Kaposi’s sarcoma, uterine sarcoma, breast cancer, small cell lung cancer, melanoma, epithelioma, cancer of the renal pelvis and ureters, bladder cancer, Wilms’ tumor, cervical cancer, germ cell tumor of the testis and ovaries, uterine choriocarcinoma, ependymoma, meningioma, pleurisy of tumor etiology, malignant tumors of the genital organs in girls. Idiopathic thrombocytopenic purpura (with resistance to corticosteroids and ineffectiveness of splenectomy).

ICD codes

Dosage Regimen

Determine the dose individually based on the specific malignancy, disease stage, and the patient’s hematological status.

Administer the drug intravenously only. Fatalities have occurred with intrathecal administration.

Calculate the dose based on body surface area (BSA). The typical adult dose is 1.4 mg/m². The single dose should not exceed 2 mg.

For pediatric patients, calculate the dose based on BSA. The typical dose is 1.5-2 mg/m².

Reduce the dose by 50% for patients with direct serum bilirubin > 3 mg/dL.

Administer doses at weekly intervals. Adjust the frequency and dose based on the specific chemotherapy protocol and patient tolerance.

Monitor the complete blood count (CBC) prior to each dose. Adjust therapy for severe myelosuppression.

Assess for signs of neurotoxicity before each administration. Reduce the dose or delay administration for severe constipation, paresthesia, muscle weakness, or loss of deep tendon reflexes.

Discontinue treatment if signs of progressive neuropathy appear.

Prevent tumor lysis syndrome with adequate hydration and consider allopurinol.

Adverse Reactions

From the hematopoietic system: leukopenia, anemia, thrombocytopenia.

From the nervous system: neuropathy, neuritis of peripheral nerves, headache, convulsions, ataxia, depression, diplopia, ptosis, hallucinations, sleep disorders.

From the urinary system: polyuria, dysuria, bladder atony, edema, acute uric acid nephropathy.

From the digestive system: vomiting, diarrhea, stomatitis, constipation, anorexia, paralytic ileus (especially often in children).

Other: alopecia (transient after discontinuation of treatment), arterial hypotension, edema.

Contraindications

Neurodystrophic diseases (in particular, the demyelinating form of Charcot-Marie-Tooth syndrome); severe liver dysfunction; threatening intestinal obstruction (especially in children); concurrent radiation therapy (especially involving the liver area); pregnancy, breastfeeding period.

With caution

Bone marrow hematopoiesis suppression, mild to moderate liver dysfunction, history of neuropathy, constipation, acute infectious diseases, previous chemotherapy or radiation therapy, use in elderly patients.

Use in Pregnancy and Lactation

Vincristine is contraindicated for use during pregnancy. If it is necessary to use during lactation, breastfeeding should be discontinued.

Women of childbearing potential receiving Vincristine should use reliable methods of contraception.

In experimental studies, the teratogenic and embryotoxic effects of vincristine have been established.

Use in Hepatic Impairment

Contraindication: severe liver dysfunction.

Use in Renal Impairment

It is used for kidney diseases according to indications.

Pediatric Use

It is possible to use in children according to indications.

Geriatric Use

Use with caution in elderly patients: the risk of neurotoxic effects is higher. If peripheral neuritis develops, the administration of vincristine should be discontinued.

Special Precautions

It is not recommended to use Vincristine in patients with chickenpox (including recently suffered or after contact with sick people), with herpes zoster, and other acute infectious diseases.

Caution should be exercised when using vincristine in gout (including in the anamnesis) and nephrolithiasis, as well as in patients who have previously received cytotoxic or radiation therapy.

The frequency of adverse effects of vincristine is related to the total dose and duration of therapy.

With simultaneous radiation therapy to the spinal cord area, the neurotoxic effect of vincristine may be enhanced.

The risk of neurotoxic effects is higher in elderly patients and individuals with a history of neurological diseases. If peripheral neuritis develops, the administration of vincristine should be discontinued.

During treatment, it is necessary to monitor the peripheral blood picture, the activity of hepatic transaminases and LDH, and the concentrations of uric acid and bilirubin in the blood plasma.

During the treatment period, vaccination of patients and their family members is not recommended.

The drug should be prescribed with caution when used concomitantly with drugs that inhibit the CYP3A isoenzyme.

In experimental studies, the carcinogenic and mutagenic effects of vincristine have been established.

Drug Interactions

With simultaneous use, Vincristine enhances the neurotoxic effects of other drugs.

With simultaneous use, Vincristine weakens the effect of antigout drugs. With simultaneous use with uricosuric agents, the risk of developing nephropathy increases.

Administration of vincristine prior to bleomycin enhances the antineoplastic effect of therapy.

Simultaneous use with mitomycin C may cause respiratory depression, bronchospasm, especially in predisposed patients.

With simultaneous use of vincristine and itraconazole, an earlier and more severe development of the neurotoxic effect is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.